臨床研究等提出・公開システム

A PHASE I, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF REVN24 IN HEALTHY MALE VOLUNTEERS

STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF REVN24 IN HEALTHY MALE VOLUNTEERS

Megumi Kai

National University Corporation Oita University Faculty of Medicine.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Recruiting

Oct. 26, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

- Signed ICF.
- Able to comply with the study protocol, in the investigators judgment.
- Have a body mass index (body weight [kg]/height [m]^2) >=18.5 kg/m^2 or <25.0 kg/m^2(Cohorts A-1 to A-10 and B-1 to B-6) or >=18.5 kg/m^2 or <30.0 kg/m^2 (Cohorts C-1 to C-5), and body weight >=50 kg at screening.
- Have no findings indicating an active or chronic disease, based on detailed hearing of medical and surgery histories and the results of physical examination, vital sign measurements, ECG, and laboratory tests.

- Clinically significant abnormal ECG at screening.
- Current cardiovascular, renal, hepatic, gastrointestinal, hematologic, immune, neurologic, endocrine, metabolic, or pulmonary disorder or a history of any of these disorders and impaired renal, hepatic, or cardiopulmonary function.

Male

Healthy Volunteer

REVN24: Single and multiple intravenous infusions of REVN24 at the indicated doses.
Placebo (REVN24 Dilution aid): Single and multiple IV infusions of placebo will be administered at the specified doses.

safety, other
- Frequency, severity and relationship of adverse events including serious adverse events (SAE) to REVN24
- Laboratory values, vital signs and ECGs

phamacokinetics, phamacodynamics

+81-92-283-7701

Aug. 31, 2023

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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